Doctors, others debate the ethics

Published 10:00 pm, Monday, July 25, 2005

Hunter Fulton, 11, practices his karate routine yesterday at Alpha Martial Arts in the Green Lake neighborhood. Hunter also has Type 1 diabetes and is in clinical trials to help with his illness.

Hunter Fulton, 11, practices his karate routine yesterday at Alpha Martial Arts in the Green Lake neighborhood. Hunter also has Type 1 diabetes and is in clinical trials to help with his illness.

Photo: Joshua Trujillo/Seattle Post-Intelligencer

Should kids be used in clinical research?

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For Hunter Fulton, the best part of participating in the advancement of medicine is the $20 gift certificates.

And what's an extra blood test each year and a few survey questions if the 11-year-old with Type 1 diabetes can help the greater good?

"I like to do it," said Hunter of Seattle's Wedgwood neighborhood. "I know that it will help them try to find a cure."

But it would be another matter if doctors wanted to test experimental drugs on him, Hunter said. He wouldn't do that -- not for $100 gift certificates. "Maybe $1 million."

That line between routine, barely invasive research and riskier clinical experimentation drives even the nation's top regulators, ethicists and researchers into intense and sometimes contentious debate. About 200 such professionals gathered in Seattle last weekend to grapple with how such studies should be regulated -- and how to deal with huge loopholes in the laws. The Center for Pediatric Bioethics, which is part of Children's Hospital and Regional Medical Center, sponsored the conference.

At the core of the debate: When is it appropriate to put children at risk to test experimental drugs or devices? But do doctors and pharmaceutical companies also have an ethical obligation to conduct research that could help sick kids?

The federal government thinks so. In recent years, the government approved valuable patent extensions to drug companies if they test their products on children -- regardless of how they conduct the studies or whether they report results.

Fulton's mother, Danielle, said she is pleased to have her son involved in the research. "I had so many questions as to why this had happened to Hunter," she said. "... To participate in the study that might help answer questions for someone else one day is important for all of us.

"The rest of his family also participated in (one of the studies) because we wanted to find out if his sister was a likely candidate for diabetes and if any of us had any of the auto-antibodies that show up."

But, like her son, Danielle Fulton would think twice about experimentation. "That's a much tougher question," she said. "I'd need a lot more information before I could make that choice."

With the number of riskier studies involving children growing in the past several years, many at the conference called for clarification in laws widely considered vague and inconsistently enforced. The federal government allows several categories of clinical experimentation -- each raising unique moral questions.

Studies can be approved if they are of "minimal risk" to the patient, or not of risk beyond those encountered in the child's "daily life."

"Whose daily life?" asked Dr. Douglas Diekema, interim director of Children's bioethics center. Should that standard be based on the lives of middle-class America? Or the poor or sick?

The government also allows riskier experiments on sick patients if the tests hold potential to directly benefit the patients involved or help other children with the same conditions.

Dr. Lainie Friedman Ross, an associate professor with the University of Chicago, said that amounts to offering greater protections to the healthy, while sometimes exploiting the ill, who tend to feel an obligation to their doctors and come from less well-educated families. Ross called for regulations that allow for greater risk for all kids, or none.

Researchers can seek special federal permission to conduct tests that offer the prospect of health benefits to all children.

Dr. Norman Fost, a professor and bioethicist at the University of Wisconsin, warned of a dangerous alternative to costly and burdensome regulations that drug companies exploit. It is a practice called "off-label use." Federal law allows doctors to use approved drugs and devices for unapproved procedures and patients, including kids.

"There's something funny going on there. And something worrisome," said Fost, who spoke about recent scandals surrounding the suicides of some children and teenagers who were given anti-depressants approved for adults.

Fost said such practices are far more dangerous than trials and that a federal prohibition against marketing off-label use is "violated all the time" by drug companies. Numerous studies have shown pharmaceutical companies successfully encourage off-label use by pouring billions of dollars into doctor training and junkets.